Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Assessment of MDD Management in Andalusia (PismaEP)

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: January 12, 2012
Last updated: August 12, 2014
Last verified: August 2014
The main objectives of this study are to describe medical professionals responsible of the management of patients with MDD in a representative region of Andalusia (in terms of type of sites managing the disease, and referral to SC criteria); Describe MDD patient characteristics at inclusion in the PISMA-Ep Study; and to evaluate those factors associated to a higher incidence of referral from PC to SC.

MDD Management Strategies

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Assessment of MDD Management Strategies in Andalusia: A Sub-analysis of the PismaEP Study

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number of Visits to Primary Care [ Time Frame: From Jan 2010 to Jan 2011 ] [ Designated as safety issue: No ]
  • Number of Visits to Secondary Care [ Time Frame: From Jan 2010 to Jan 2011 ] [ Designated as safety issue: No ]
  • Number of Referrals [ Time Frame: From Jan 2010 to Jan 2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Demographics [ Time Frame: From Jan 2010 to Jan 2011 ] [ Designated as safety issue: No ]
  • Type of site [ Time Frame: From Jan 2010 to Jan 2011 ] [ Designated as safety issue: No ]
  • Type of therapeutic strategy [ Time Frame: From Jan 2010 to Jan 2011 ] [ Designated as safety issue: No ]
  • Type of disease [ Time Frame: From Jan 2010 to Jan 2011 ] [ Designated as safety issue: No ]
  • Severity of disease [ Time Frame: From Jan 2010 to Jan 2011 ] [ Designated as safety issue: No ]

Enrollment: 5309
Study Start Date: June 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

Detailed Description:
Assessment of MDD management strategies in Andalusia: A Sub-analysis of the PismaEP Study

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
MDD patients treated in Primary Care or Secondary Care in the Region of Granada and recruited for the PISMA-Ep Study

Inclusion Criteria:

  • MDD Diagnosis Participants of the PismaEP study 18 yo. or older

Exclusion Criteria:

  • No specific exclusion criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01510886

Research Site
Granada, Spain
Sponsors and Collaborators
Principal Investigator: Jorge Cervilla, MD Hospital San Cecilio
  More Information

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT01510886     History of Changes
Other Study ID Numbers: NIS-NES-XXX-2011/3  PismaEP 
Study First Received: January 12, 2012
Last Updated: August 12, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by AstraZeneca:
MDD, management, Andalusia, Database, PismaEP processed this record on December 02, 2016